Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID07140016

A Phase 1b Study of Gilteritinib in Adults With Locally Advanced or Metastatic ALK-positive Non-small Cell Lung Cancer After Prior ALK Inhibitor Treatment

Led by Astellas Pharma Global Development, Inc. · Updated on 2026-06-08

40

Participants Needed

15

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and tolerability of gilteritinib in adults with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have stopped responding to prior ALK inhibitor treatments such as alectinib or lorlatinib. ALK-positive NSCLC is caused by changes in the ALK gene, and while ALK inhibitors are approved treatments, resistance can develop over time. Gilteritinib, already approved for a type of leukemia, may block changes in the ALK gene and provide a new option for these patients. Participants will take gilteritinib tablets once daily in 28-day cycles. The study allows for two doses: participants start on a lower dose and may switch to a higher dose if they tolerate the treatment and show stable disease after scans. Treatment continues until cancer progression, intolerable side effects, participant choice to stop, starting other cancer therapy, or death. After stopping gilteritinib, participants have follow-up visits about 7 and 30 days later, with ongoing tumor scans if cancer has not worsened. During the study, participants will have regular tumor scans and safety checks including medical assessments and monitoring of side effects. After completing treatment, researchers will continue to check on participants' health by phone every 12 weeks for up to four years, depending on their response. The study measures side effects, safety outcomes, tumor response, survival, and drug levels in the blood to understand the effects of gilteritinib in this population.

CONDITIONS

Brief Title

A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to have ALK gene rearrangement
  • Willing to provide a fresh or archival tumor tissue sample before starting study drug
  • Have received at least one prior ALK inhibitor therapy including alectinib or lorlatinib
  • Have measurable disease based on RECIST version 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Experienced disease progression during or after the most recent therapy
  • Female participants must not be pregnant and follow contraceptive guidelines; must not breastfeed during and after the study
  • Male participants must agree to contraception and avoid sperm donation during and after the study
  • Meet clinical laboratory test criteria
  • Agree not to participate in another interventional study during this study
Not Eligible

You will not qualify if you...

  • Have oncogenic driver mutations other than ALK rearrangement
  • Have symptomatic central nervous system metastases or leptomeningeal metastasis
  • History of other cancers within 2 years except certain treated skin or cervical cancers
  • Had major surgery within 4 weeks before starting the study or plan surgery during the study
  • Ongoing moderate or higher toxicity from prior cancer treatment (except hair loss)
  • Recent febrile illness or active infection within 28 days before study drug
  • History of serious heart conditions or recent heart-related events
  • History of interstitial pneumonia
  • Received cancer therapies within 14 days before study drug
  • Require treatment with certain medications that interact with the study drug
  • Received investigational therapy recently
  • Prolonged QT interval on ECG
  • Active hepatitis B or C infection without appropriate treatment or monitoring
  • Known HIV infection with AIDS-related complications
  • Reduced heart pumping function (ejection fraction below 45%)
  • Known allergy or sensitivity to gilteritinib or its components
  • Any condition making participation unsafe or unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated 28-day cycles until disease progression or discontinuation

Participants will take gilteritinib orally once daily in 28-day cycles. Dose adjustments may be made for those who tolerate the drug and achieve stable disease after two scans.

Regular visits for dosing and assessments as per study schedule

Trial Site Locations

Total: 15 locations

1

University of California - Irvine

Orange, California, United States, 92868

Actively Recruiting

2

Emory Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

3

OSF Health Care

Peoria, Illinois, United States, 61637

Actively Recruiting

4

University of Michigan Health Systems

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

5

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

6

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

7

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States, 75390

Actively Recruiting

8

Virginia Cancer Specialists PC

Fairfax, Virginia, United States, 22031

Actively Recruiting

9

Site FR33008

Saint-Herblain, France

Actively Recruiting

10

Site FR33005

Toulouse, France

Actively Recruiting

11

Site FR33001

Villejuif, France

Actively Recruiting

12

Site ES34017

Barcelona, Spain

Actively Recruiting

13

Site ES34006

Madrid, Spain

Actively Recruiting

14

Site ES34011

Madrid, Spain

Actively Recruiting

15

Site ES34008

Málaga, Spain

Actively Recruiting

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Research Team

A

Astellas Pharma Global Development, Inc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Successful and On-going Long-Term Disease Control (>24 Months) with Gilteritinib in an ALK+ NSCLC Patient with Brain Metastasis Who Has Progressed on Multiple ALK TKIs. A Case Report and Review of Literature on Gilteritnib.

Sai-Hong Ignatius Ou, Cathleen June Park, Zhaohui Liao Arter...

https://pubmed.ncbi.nlm.nih.gov/41158152